Using digital devices to monitor respiratory virus infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to utilize wearable and sensor devices, such as smartwatches and smartphones, to collect health data from participants enrolled in respiratory virus challenge studies. Participants will wear these devices continuously during their stay at the NIH Clinical Center and during follow-up visits to monitor various health metrics, including cough frequency, heart rate, and temperature. The goal is to identify digital biomarkers that correlate with respiratory virus infections and develop predictive models for influenza disease severity. By analyzing the data collected, researchers hope to uncover subtle health changes that may indicate infection.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Able to provide informed consent.
2. Current, recent, or planned enrollment in a respiratory virus challenge study at the NIH Clinical Center.
3. Willing to wear devices as instructed.
4. Willing to participate in monitoring activities as instructed.
5. Willing to have monitoring data stored.
6. Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.
7. Willing to have select clinical data from the challenge study such as vital signs, viral shedding, pulmonary function test and/or spirometry results, and clinical symptoms data shared with investigators at University of Washington and University of Toronto.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1\. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Co-enrollment guidelines: Participants must be co-enrolled, planned for co-enrollment, or recently enrolled in a challenge study. Co-enrollment in other studies is restricted but may take place after study staff notification and only with approval of the principal investigator or designee.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Luca T Giurgea, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Rani S Athota, Ph.D.
• Email: rani.athota@nih.gov
• Phone: (301) 594-0803

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.